BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL S/C 200

    MDR report key: 21905897 · Received April 24, 2025

    Report

    Report Number
    1213809-2025-00306
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    January 6, 2025
    Report Date
    June 5, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). SUPPLEMENTAL MDR - FOREIGN MATTER. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 302995 BATCH#: 4310750. RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT PROBLEM REPORT PRODUCT INFORMATION PRODUCT CODE: 302995 PRODUCT DESCRIPTION: SYRINGE HYPO 10CC L/L BX/200 LOT/SERIAL #: (B)(6) EXPIRY DATE: 2029-10-31. PROBLEM INFORMATION PRODUCT CONCERN TICKET NUMBER: (B)(4) DATE OF INCIDENT: (B)(6) 2025 CONCERN DESCRIPTION: WHILE PUSHING PROPOFOL INTO THE PATIENT, THE NURSE NOTED A NOTABLE SIZED BLACK SPECK IN THE SYRINGE. IT POSSIBLY IS A PIECE OF THE RUBBER FROM THE PLUNGER INSIDE THE SYRINGE. THANKFULLY RUBBER PIECE DID NOT INJECT INTO THE PATIENT. OCCURRENCES: 1 EA. SAMPLE INFORMATION INCIDENT SAMPLES: 1 EA REPRESENTATIVE SAMPLES: 0.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192338 BD SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4310750 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown